FDA.reportPublic FDA data

Elecsys FT3 III

Primary DI
04015630934171
Brand
Elecsys FT3 III
Company
Roche Diagnostics GmbH
Model
6437206160
Catalog number
6437206160
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CDPRADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDPRadioimmunoassay, Total TriiodothyronineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963127000ELECSYS FT3Boehringer Mannheim Corp.1996-12-16CDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630934171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630934171040156309341714015630934171

GMDN Terms#

Term, Definition table
TermDefinition
Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of free triiodothyronine (FT3) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
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07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026446AccuDiag™ T3 ELISA KitDiagnostic Automation, Inc.CDP2026-03-02
14562185395447CL AIA-PACK T3 TEST CUPTOSOH CORPORATIONCDP2025-09-01
24562185395444CL AIA-PACK T3 TEST CUPTOSOH CORPORATIONCDP2025-09-01
00840239023858Free Triiodothyronine (fT3) ELISADRG International IncCDP2024-09-23
00840239038012Free T3 ELISADRG International IncCDP2024-09-23
00840239053565T3 freeDRG International IncCDP2024-09-23
04048474023855Free Triiodothyronine (fT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
04048474038019Free T3 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
04048474053562T3 freeDRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
00840239056979T-3DRG International IncCDP2024-08-13
04048474056976T-3DRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-08-13
B24220TT3HUE011Total Triiodothyronine (Total T3) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CDP2024-07-22
04048474052756Total Triiodothyronine (tT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-09-01
04048474052770Free Triiodothyronine (fT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-09-01
04048474041071Free Triiodothyronine (fT3) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-31
04048474045697T3 Total ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-31
04048474017809Triiodothyronine (T3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-29
00840239045690T3 Total ELISA DRG International IncCDP2023-08-25
00840239052759Total Triiodothyronine (tT3) ELISADRG International IncCDP2023-08-25
15099590201661Access Free T3Beckman Coulter, Inc.CDP2023-06-26
15099590227210Access Total T3Beckman Coulter, Inc.CDP2023-06-26
00894175000886AccuDiag ™Diagnostic Automation, Inc.CDP2023-06-14
00850049545976QmedixDiagnostic Automation, Inc.CDP2023-06-13
10758750033782VITROSORTHO CLINICAL DIAGNOSTICSCDP2023-03-28
04049016139232Free Triiodothyronine (FT3) ELISAEUROIMMUN Medizinische Labordiagnostika AGCDP2022-12-08
06925912718505iFlash-T3Shenzhen YHLO Biotech Co., Ltd.CDP2022-10-26
07613336171578Elecsys FT3 IIIRoche Diagnostics GmbHCDP2021-10-02
07613336171585Elecsys FT3 IIIRoche Diagnostics GmbHCDP2021-10-02
07613336171646Elecsys T3Roche Diagnostics GmbHCDP2021-08-13
07613336171653Elecsys T3Roche Diagnostics GmbHCDP2021-08-13